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Drug Safety Alerts
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/0.025 mg Tablets Consumer-Level Recall
11/17/17
On November 17, 2017, the United States issued a notice regarding a consumer-level recall of diphenoxylate hydrochloride and atropine sulfate 2.5 mg/0.025 mg tablets manufactured by Greenstone, a wholly owned subsidiary of Pfizer Inc. This recall was issued because the product has the potential to be super potent or sub potent.
A complete list of the affected products and lot numbers is provided here.
The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. The product label states that over dosage can be life-threatening and symptoms may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech. Respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression are improbable. If a patient was to receive a sub potent tablet, symptoms may not be controlled. To date, there have been no reports of adverse events related to this recall.
CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.
For more information about this recall, health care providers may contact Pfizer Medical Information at 1-800-438-1985 and select option 3, Monday through Friday, 8:00 am to 7:00 pm (ET) or visit https://www.greenstonellc.com/node/1286.
You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov/Safety/Recalls/ucm585708.htm.